MEDXF - Medexus medac refile seeking FDA nod for Treosulfan in cancer patients undergoing stem-cell transplant

Medexus Pharmaceuticals (OTCQX:MEDXF) said its German partner medac resubmitted a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for Treosulfan, in combination with chemotherapy fludarabine, as a preparative regimen for patients with certain types of cancer undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). The FDA had rejected the drug in 2021 noting that it could approve the NDA in its present form but recommendations specific to additional clinical/statistical data and analyses pertaining to the main and secondary goals of the completed phase 3 study. Medexus (OTCQX:MEDXF) said in an April 22 press release that the resubmission includes additional clinical data and statistical analysis related to the the phase 3 study and update of an integrated summary of safety, which the FDA had requested in the Complete Response Letter to Medac. "We are very hopeful for a favorable FDA decision and believe that, if approved, Treosulfan will become the new standard of

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Medexus, medac refile seeking FDA nod for Treosulfan in cancer patients undergoing stem-cell transplant